Regulations on biosafety regulations in pathogenic microbiology laboratories

Chapter 1 GeneralArticle 1 These Regulations are formulated in order to strengthen the biosecurity management of the Pathogen Microbiology Laboratory (hereinafter referred to as the Laboratory) and to protect the health of laboratory staff and the publicArticle 2 These Regulations shall apply to laboratories within the People's Republic of China and the biosecurity management of their experimental activitiesthe term "pathogenic microorganisms" as mentioned in these Regulations, which refer to microorganisms that can cause disease to humans or animalsthe experimental activities referred to in these Regulations, refer to the laboratory engaged in research, teaching, testing, diagnosis and other activities related to pathogenic microbial bacteria (toxic) species and samplesArticle 3 The competent department of health under the State Council shall be in charge of the biosafety supervision of laboratories and their experimental activities related to human healththe competent department of veterinary medicine under the State Council shall be in charge of the biosafety supervision of laboratories and their experimental activities related to animalsother relevant departments of the State Council are responsible for the biosecurity management of laboratories and their experimental activities within their respective areas of responsibilitylocal people's governments at or above the county level and their relevant departments shall be responsible for the biosecurity management of laboratories and their experimental activities within their respective areas of responsibilityArticle 4 The State shall carry out the classification management of pathogenic microorganisms and the classification management of laboratoriesArticle 5 of theThe State shall implement uniform laboratory biological safety standardsThe laboratory shall comply with national standards and requirementsThe establishment unit of the laboratory and its competent department shall be responsible for the management of the day-to-day activities of the laboratory, and shall undertake the responsibility of establishing and perfecting the safety management system, inspecting and maintaining experimental facilities and equipment, and controlling the infection of the laboratory"style"text-align: center;"img src""alt"""biosafety regulations for pathogenic microbiology laboratories" title""pathogenic microbiology laboratory biosafety regulations"Chapter II Classification and Management of Pathogenic Microbes article 7The State divides pathogenic microorganisms into four categories according to the infectious nature of pathogenic microorganisms and the degree of harm to individuals or groups after infection: the first class of pathogenic microorganisms, which refers to microorganisms that can cause very serious diseases in humans or animals, and microorganisms that have not yet been discovered or declared eliminated in China the second class of pathogenic microorganisms, refers to the human or animal can cause serious diseases, it is easier to directly or indirectly spread between people, animals and animals the third class of pathogenic microorganisms, refers to microorganisms that can cause human or animal diseases, but generally do not pose serious harm to humans, animals or the environment, have limited risk of transmission, rarely cause serious diseases after laboratory infection, and have effective treatment and preventive measures class IV pathogenic microorganisms, which are microorganisms that would not normally cause human or animal diseases the first and second pathogenic microorganisms are collectively referred to as highly pathogenic pathogenic microorganisms Article 8 The list of pathogenic microorganisms transmitted by humans shall be formulated, adjusted and published by the competent department of health under the State Council after the relevant departmentof of the State Council; Article 9 Of the following conditions shall be met with the following conditions: (1) have equipment appropriate to the level of biosecurity protection required for the collection of pathogenic microbial samples; (2) staff with relevant professional knowledge and operational skills, (3) have effective measures to prevent the spread and infection of pathogenic microorganisms; and (4) have technical methods and means to ensure the quality of pathogenic microbial samples the collection of highly pathogenic pathogenic microbial samples of staff should prevent the spread and infection of pathogenic microorganisms in the collection process, and the sample source, collection process and methods, etc to make detailed records Article 10 The transport of highly pathogenic pathogenic microbial bacteria (toxic) species or samples shall be transported by land; if there is no land passage, it must be transported by water; and in case of emergency or the need to transport the highly pathogenic pathogenic microbial bacteria (toxic) species or samples abroad, they may be transported by civil aviation Article 11 The transport of highly pathogenic pathogenic microorganisms (toxic) species or samples shall be subject to the following conditions: (1) the purpose of transport, the use of highly pathogenic pathogenic microorganisms and the receiving unit in accordance with the provisions of the competent department of health or veterinary medicine under the State Council; The container of the species or sample shall be sealed, and the container or packaging material shall also comply with the requirements of waterproofing, anti-breakage, anti-leakage, high (low) temperature and high pressure resistance; the (3) container or packaging material shall be printed with the biological danger marks, warning terms and warning terms prescribed by the competent department of health or veterinary medicine under the State Council transport ingestion of highly pathogenic pathogenic microorganisms (toxic) species or samples shall be approved by the competent department of health or veterinary medicine of the people's government at or above the provincial level Where transportation is carried out within the administrative area of a province, autonomous region or municipality directly under the Central Government, it shall be approved by the competent department of health or veterinary medicine of the people's government of the province, autonomous region or municipality directly under the central government; if it is required to be transported across provinces, autonomous regions or municipalities directly under the Central Government or shipped abroad, the competent department of health or veterinary medicine of the people's government of the province, autonomous region or municipality directly under the central government shall, after the preliminary examination, be reported to the competent department of health or veterinary medicine under the State Council for approval if an entry-exit inspection and quarantine institution needs to transport samples of pathogenic microorganisms during the inspection and quarantine process, it shall be approved by the entry-exit inspection and quarantine department under the State Council and shall at the same time notify the competent department of health or veterinary medicine under the State Council transporting highly pathogenic pathogenic microbial bacteria (toxic) species or samples by civil aviation, in addition to obtaining approval in accordance with the provisions of paragraphs 2 and 3 of this Article, shall also be approved by the competent civil aviation authority under the State Council the relevant competent departments shall examine the application materials submitted by the applicant for the transport of highly pathogenic microbial bacteria (toxic) species or samples, and shall immediately approve those who meet the conditions stipulated in the first paragraph of this Article